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1. Purpose
The purpose of this Validation Summary Report is to summarize the finding of the validation of test method
Determination of , following Validation Protocol ..
2. Scope/Test Method Description
Optional: may be restated from the protocol.
3.
Background
Optional: may be restated from the protocol.
4. Strategy
Optional: may be restated from the protocol.
5.
Procedures
Include synopsis of procedure for execution of validation of each characteristic. Include acceptance criteria for
each characteristic.
5.1. Accuracy
Accuracy should be reported as percent recovery of the known added amount or as the difference
between the mean and the accepted true value together with the confidence intervals.
The concentration ranges used should be stated, as should the number of replicates tested.
In the table, the terms concentration 1, 2, and 3 should be replaced with the actual concentrations used
in the experiments. Additional rows may be added if more concentrations were tested.
Table: % Recovery & Difference between Mean and Accepted Value
Analyte
Level
Actual
Concentration
Individual %
Recovery
Mean %
Recovery
P/F
% RSD
P/F
Level 1
Acceptance Criteria
Level 2
Acceptance Criteria
Level 3
Acceptance Criteria
5.2. Precision
5.2.1. Method Precision
Describe the experiments to determine repeatability. Appropriate table shells for this section are
provided below. This table assumes 3 replicate sample preparations at 3 concentrations and assumes
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quantitation of the results. In cases where visual inspection is used, replicate chromatograms may be
used in place of tables.
Analysis Repeatability Using Different Concentrations
Analyte
Level
Concentration
Level 1
Amount of
Analyte
Replicate 1
Replicate 2
Replicate 3
Acceptance Criteria
Concentration
Level 2
Replicate 1
Replicate 2
Replicate 3
Acceptance Criteria
Concentration
Level 3
Replicate 1
Replicate 2
Replicate 3
Acceptance Criteria
Measured
parameter
Mean
% RSD
P/F
Measured parameter
Replicate 1
Replicate 2
Replicate 3
Replicate 4
Replicate 5
Replicate 6
Mean
% RSD
Acceptance Criteria
P/F
5.2.2.Intermediate Precision
Depending on the nature of the analysis and results visual inspection or quantitative data, either
the appropriate figures or table should be included in this section. The table below shows a sample
layout for reporting intermediate precision where quantitative data is obtained.
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Determination
Analyst 2 /Lab2/Day 2
Sample 1
Sample 2
Sample 3
Sample 4
Sample 5
Sample 6
Mean (N=6)
% RSD (N=12)
Acceptance Criteria (N=12)
P/F
5.3. Specificity
Provide representative figures of a placebo, representative sample, and a stressed sample.
Figure 1: Placebo Sample
Figure 2: Representative Sample
Figure 3: Stressed Sample
Discuss the results of the specificity experiments. If method specificity is not demonstrated, describe
how additional test methods in combination with this test method are used to provide the appropriate
specificity.
Stress Condition
Heat
Oxidation
Humidity
Light
Acid
Base
Purity Angle
Purity Threshold
% Degradation
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Level
Concentration Level relative nominal working
standard in %
Area
Actual Concentration
Concentration 1
Concentration 2
Concentration 3
Concentration 4
Concentration 5
Slope
y-intercept
Correlation Coefficient Acceptance Criteria r 0.XXX
P/F
Analyte S/N
Analyte
Peak Area
Analyte
S/N
% RSD XX.0%
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5.7. Robustness:
Standard Solution Stability
Time
2 8 C
Room Temperature
% of Analyte
% Difference
P/F
% of Analyte
% Difference
P/F
Day 0
Day x
Day Y
Day Z
Sample Solution Stability
Time
2 8 C
Room Temperature
% of Analyte
% Difference
P/F
% of Analyte
% Difference
P/F
Day 0
Day x
Day Y
Day Z
Method Parameter
RRT
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